Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword.
Fanelli, Flaminia Peitzsch, Mirko Bruce, Stephen Cantù, Marco Temchenko, Anastasia Mezzullo, Marco Lindner, Johanna M Hawley, James M Ackermans, Mariette T Van den Ouweland, Jody
Fanelli, Flaminia
Peitzsch, Mirko
Bruce, Stephen
Cantù, Marco
Temchenko, Anastasia
Mezzullo, Marco
Lindner, Johanna M
Hawley, James M
Ackermans, Mariette T
Van den Ouweland, Jody
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2024-01-12
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Abstract
Objectives: Current LC-MS/MS applications for circulating androgen measurements are technically diverse. Previously, variable results have been reported for testosterone. Data are scarce for androstenedione and absent for DHEAS. We assessed the agreement of androstenedione, DHEAS and testosterone LC-MS/MS measurements among nine European centers and explored benefits of calibration system unification.
Methods: Androgens were measured twice by laboratory-specific procedures in 78 patient samples and in EQA materials. Results were obtained by in-house and external calibration. Intra- and inter-laboratory performances were valued.
Results: Intra-laboratory CVs ranged between 4.2-13.2 % for androstenedione, 1.6-10.8 % for DHEAS, and 4.3-8.7 % and 2.6-7.1 % for female and male testosterone, respectively. Bias and trueness in EQA materials were within ±20 %. Median inter-laboratory CV with in-house vs. external calibration were 12.0 vs. 9.6 % for androstenedione (p<0.001), 7.2 vs. 4.9 % for DHEAS (p<0.001), 6.4 vs. 7.6 % for female testosterone (p<0.001) and 6.8 and 7.4 % for male testosterone (p=0.111). Median bias vs. all laboratory median with in-house and external calibration were -13.3 to 20.5 % and -4.9 to 18.7 % for androstenedione, -10.9 to 4.8 % and -3.4 to 3.5 % for DHEAS, -2.7 to 6.5 % and -11.3 to 6.6 % for testosterone in females, and -7.0 to 8.5 % and -7.5 to 11.8 % for testosterone in males, respectively.
Conclusions: Methods showed high intra-laboratory precision but variable bias and trueness. Inter-laboratory agreement was remarkably good. Calibration system unification improved agreement in androstenedione and DHEAS, but not in testosterone measurements. Multiple components, such as commutability of calibrators and EQA materials and internal standard choices, likely contribute to inter-laboratory variability.
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Fanelli F, Peitzsch M, Bruce S, Cantù M, Temchenko A, Mezzullo M, Lindner JM, Hawley JM, Ackermans MT, Van den Ouweland J, Koeppl D, Nardi E, MacKenzie F, Binz PA, Rauh M, Keevil BG, Vogeser M, Eisenhofer G, Heijboer AC, Pagotto U. Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword. Clin Chem Lab Med. 2024 Jan 12;62(6):1080-1091. doi: 10.1515/cclm-2023-1138.
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